Fujifilm Medical Systems USA said its digital breast tomosynthesis (DBT) optional software upgrade has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA).
The optional upgrade for the Aspire Cristalle digital mammography system is now available in the U.S.
Aspire Cristalle is known as Amulet Innovality outside of the U.S. Fuji's optional DBT upgrade has been widely available in Europe, Asia, and Latin America since May 2013, the firm said.
